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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K842503
Device Name GAMBRO PULSATILE MONITOR PLM 10-200
Applicant
Gambro, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gambro, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4380
Classification Product Code
DWA  
Date Received06/26/1984
Decision Date 08/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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